Multisite Feeding Study: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle
This study will assess 75-100 patients for feeding issues following surgery for single ventricle.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle|
- weight gain [ Time Frame: 5 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||June 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
We wish to consent 75-100 subjects at Children's Healthcare of Atlanta.
If subjects take part in this study, the following will happen:
- Prior to discharge, the parent/guardian will be given a home feeding log and
- Parents will bring the feeding log to regularly scheduled clinic visits. Clinic staff will also weigh the child and measure head circumference at each clinic visit.
- The investigators will look at the child's medical record to obtain other information including diagnosis, surgery, oxygen saturation levels and medications.
The parent/guardian will be asked to fill out a questionnaire about their stress and uncertainty caring for their baby after heart surgery. They will be asked to fill out the same questionnaire 3 times:
- First time will be before they leave the hospital after the baby's surgery, while still a patient on the Cardiac Step Down Unit (CSU).
- Second time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 4 weeks.
- Third time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 12 weeks or at the time of the routine cardiac cath prior to their second stage surgery.
It should take about 15 minutes to fill out the questionnaire. The questionnaire is the only research procedure.
The data from the feeding log and clinic visits will be submitted to Cincinnati Children's, the primary site for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257517
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Martha Clabby, MD||Children's Healthcare of Atlanta|